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Trial registered on ANZCTR

Registration number

ACTRN12615000018516

Ethics application status

Approved

Date submitted

4/12/2014

Date registered

15/01/2015

Date last updated

23/11/2018

Date data sharing statement initially provided

23/11/2018

Date results provided

23/11/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Does subcutaneous fat measured at 1820 weeks predict difficulty inserting an epidural or adverse pregnancy outcomes?

Scientific title

In pregnant women, does the abdominal subcutaneous fat measured by ultrasound at 18-22 weeks predict pregnancy outcomes or difficulty of insertion of neuraxial anaesthesia?

Secondary ID [1]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Pregnancy

Adiposity measured by subcutaneous fat

Condition category

Condition code

Reproductive Health and Childbirth

Fetal medicine and complications of pregnancy

Anaesthesiology

Other anaesthesiology

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Abdominal subcutaneous fat measured by ultrasound at 18-22 weeks gestation, as a measure of central adiposity.

Part 1: SCF measured at 18-22 weeks gestation will be analyzed against obesity-related pregnancy outcomes (maternal and fetal) to determine if it can be used to predict such outcomes. The observation period will last from the time the measurement is taken until the week after the fetus has been delivered.

Part 2. In women booked for elective caesarean section, the measurement of subcutaneous fat taken at 18-22 weeks gestation will be analysed against the anaesthetist's difficulty palpating landmarks, the number of insertion attempts and the US measurement of lumbar subcutaneous fat. The aim is to determine if the SCF measurement can be used to predict these outcomes. The observation period will last from the time of the SCF measurement, until the completion of the anaesthetic.

Intervention code [1]

Not applicable

Comparator / control treatment

Nil

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Maternal outcome
(pre-eclampsia, gestational diabetes, haemorrhage requiring transfusion, mode of delivery)

Timepoint [1]

Antenatal (at 18-22 weeks gestation)
Post-natal (1 week after delivery of the fetus)

Primary outcome [2]

Fetal Outcome
Birth weight, length and head circumference, APGAR score at 5 minutes, hypoglycaemia, gestation, respiratory support, destination,

Timepoint [2]

First 48 hours of life

Primary outcome [3]

Difficulty palpating lumbar landmarks
This will be rated by the treating anaesthetist at the time of palpation as easy (easily able to palpate lumbar spinous processes at multiple levels in sitting position with minimal/moderate compression of subcutaneous tissue), moderate (able to palpate L3/4 spinous process in sitting position with significant compression of subcutaneous tissues in optimal position) or hard (unable to palpate lumbar spinous process despite significant compression and optimal positioning)

Timepoint [3]

At the time of anaesthesia for elective caesarean section

Secondary outcome [1]

Difficulty inserting neuraxial
Rated by the anaesthetist as easy, moderate or hard (definitions available)
Number of insertions of the needle through the skin, number of re-directions of the needle within the back

Timepoint [1]

At the time of anaesthetic for elective caesarean section

Eligibility

Key inclusion criteria

All participants must be pregnant (pregnancy is the "health condition" required for eligibility)
For part 1: all women presenting to the RBWH for an 18-22 week scan and do not opt-out.
For part 2: Women booked for elective caesarean section (Category 4);
women who have had a SCF measurement taken at the RBWH on their 18-22 week USS; women who are reasonably expected to have regional anaesthesia for their caesarean section.

Minimum age

16 Years

Maximum age

45 Years

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

Part 1: For the purposes of analysis exclusion criteria will be: referral to the alcohol and drugs service for significant drug or alcohol use; failure to attend at least one antenatal appointment.
Part 2: Participants who do not have regional anaesthesia, or have an emergency caesarean section (category 1,2,3).

Study design

Purpose

Duration

Longitudinal

Selection

Convenience sample

Timing

Prospective

Statistical methods / analysis

For Part 1, the SCF will be measured for 12 months which should yield between 800-1000 measurements - statistical advice is that this will be sufficient. The SCF measurement will be analysed according to the outcome data, to determine if there is a relationship between the SCF thickness and any of the outcome variables. ANOVA, Chi square and multiple logistic regression will be used. For Part 2, the sample size is currently being calculated from a pilot study but will be in the order of 100-200 (Part 1 will commence while this number is being finalised). The number of attempts inserting the epidural and the difficulty palpating landmarks will be analysed against the SCF measurement using ANOVA and Chi-square.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

2/03/2015

Actual

2/03/2015

Date of last participant enrolment

Anticipated

6/03/2017

Actual

13/06/2016

Date of last data collection

Anticipated

Actual

13/06/2018

Sample size

Target

1000

Accrual to date

Final

997

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Royal Brisbane & Womens Hospital - Herston

Recruitment postcode(s) [1]

4006 - Herston

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

The Royal Brisbane and Women's Hospital
Department of Anaesthesia and Perioperative Medicine

Address [1]

Butterfield St
Herston, 4006
QLD

Country [1]

Australia

Funding source category [2]

University

Name [2]

The University of Queensland

Address [2]

St Lucia
QLD 4072

Country [2]

Australia

Primary sponsor type

Hospital

Name

The Royal Brisbane and Women's Hospital

Address

Butterfield St
Herston, 4006
QLD

Country

Australia

Secondary sponsor category [1]

University

Name [1]

The University of Queensland

Address [1]

St Lucia
QLD 4072

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

HREC of the Royal Brisbane and Women's Hospital

Ethics committee address [1]

Level 7, Block 7.
Butterfield St
Herston 4006
QLD

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

03/12/2014

Ethics approval number [1]

HREC/14/QRBW/492

Summary

Brief summary

This study will test two hypotheses and consist of two parts:
1. Part 1.  The thickness of abdominal SCF, measured by ultrasound at 18-22 weeks gestation, predicts maternal outcomes (gestational diabetes, pregnancy-related hypertensive disorders, mode of delivery) and fetal outcomes (estimated fetal weight, birth outcome, gestational age, gender, weight, length, head circumference, large for gestational age, small for gestational age, intrauterine growth restriction).
2.  Part 2.  The thickness of abdominal SCF, measured by ultrasound at 18-22 weeks gestation, predicts the difficulty inserting an epidural, the difficulty palpating the landmarks of epidural insertion and the subcutaneous fat measured at lumbar interspace L3-4.

Trial website

Trial related presentations / publications

Increased maternal abdominal subcutaneous fat thickness and body mass index are associated with increased cesarean delivery: A prospective cohort study.
Acta Obstetricia et Gynecologica Scandinavica  DOI: 10.1111/aogs.13486

Public notes

Contacts

Principal investigator

Name

Dr Victoria Eley

Address

The Royal Brisbane and Women's Hospital (RBWH)
Butterfield St
Herston 4006
QLD

Country

Australia

Phone

+617 38127616

Fax

[email protected]

Contact person for public queries

Name

Victoria Eley

Address

RBWH
Butterfield St
Herston 4006
QLD

Country

Australia

Phone

+61738127616

Fax

[email protected]

Contact person for scientific queries

Name

Victoria Eley

Address

RBWH
Butterfield St
Herston 4006
QLD

Country

Australia

Phone

+617438127616

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	Citations or Other Details
Study results article	Yes	Eley VA, Chin A, Sekar R, Donovan T, Krepska A, Be... [More Details]
Study results article	Yes	Eley VA, Chin A, Sekar R, Donovan T, Krepska A, Be... [More Details]
Plain language summary	No	Maternal abdominal SCFT and BMI were both signific... [More Details]

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically